POOLE TIP SUCTION PROBE

Laryngoscope, Endoscope

O.R. CONCEPTS, INC.

The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Poole Tip Suction Probe.

Pre-market Notification Details

Device IDK915762
510k NumberK915762
Device Name:POOLE TIP SUCTION PROBE
ClassificationLaryngoscope, Endoscope
Applicant O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke,  TX  76262
ContactJohn Mayall
CorrespondentJohn Mayall
O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke,  TX  76262
Product CodeGCI  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-24
Decision Date1992-03-13

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